New Pediatric Labeling Information Database - Detail

Please note: JavaScript must be enabled for this application to work properly.
Check your settings if you are unsure
if your JavaScript is enabled.

Pediatric Labeling Date:

03/30/2001

Trade Name:

Ultane

Generic Name or Proper Name (*):

sevoflurane

Indications Studied:

Induction and maintenance of general anesthesia

Label Changes Summary:

* New study in pediatric patients 9 days-12 years comparing sevoflurane and halothane * Precautions section and Adverse Events During Post-Marketing subsection updated to add information on the rare cases of seizures that have been reported in pediatric patients in association with sevoflurane use. The majority of cases were in children and young adults, most of whom had no medical history of seizures * Pediatric information consolidated into new Pediatric Use subsection